A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1

NCT ID: NCT07275606

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-17
• Study Completion Date: 2029-10-10

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of cabotegravir in neonates exposed to human immunodeficiency virus (HIV)-1.

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Stage 1: Single Oral Dose CAB (Cohort 1) group

Participants receive a single dose of oral CAB suspension on study Day 1.

Group Type: EXPERIMENTAL

Oral CAB

Intervention Type: DRUG

CAB administered once orally on study Day 1 to the Stage 1: Single Oral Dose CAB (Cohort 1) and multiple times to the Stage 1: Multiple Oral Dose CAB (Cohort 2) group. Dose and dosing frequency for Cohort 2 to be determined based on emerging data from Cohort 1.

Stage 1: Multiple Oral Dose CAB (Cohort 2) group

Participants receive repeat doses of oral CAB suspension starting on study Day 1. Dose and dosing frequency to be determined based on data from Cohort 1.

Group Type: EXPERIMENTAL

Oral CAB

Intervention Type: DRUG

CAB administered once orally on study Day 1 to the Stage 1: Single Oral Dose CAB (Cohort 1) and multiple times to the Stage 1: Multiple Oral Dose CAB (Cohort 2) group. Dose and dosing frequency for Cohort 2 to be determined based on emerging data from Cohort 1.

Stage 2: Single IM Dose CAB LA (Cohort 3) group

Participants receive a single IM dose of CAB LA on study Day 1. Dose to be determined based on data from Cohort 2.

Group Type: EXPERIMENTAL

IM CAB LA

Intervention Type: DRUG

CAB LA administered once intramuscularly on study Day 1 to the Stage 2: Single IM Dose CAB LA (Cohort 3) group and multiple times to the Stage 2: Multiple IM Dose CAB LA (Cohort 4) group, into the in the anterolateral thigh muscle of participants. Dose for Cohort 3 to be determined based on emerging data from Cohort 2. Dose and dosing frequency for Cohort 4 to be determined based on emerging data from Cohort 3.

Stage 2: Multiple IM Dose CAB LA (Cohort 4) group

Participants receive repeat IM doses of CAB LA starting on study Day 1. Dose and dosing frequency to be determined based on data from Cohort 3.

Group Type: EXPERIMENTAL

IM CAB LA

Intervention Type: DRUG

CAB LA administered once intramuscularly on study Day 1 to the Stage 2: Single IM Dose CAB LA (Cohort 3) group and multiple times to the Stage 2: Multiple IM Dose CAB LA (Cohort 4) group, into the in the anterolateral thigh muscle of participants. Dose for Cohort 3 to be determined based on emerging data from Cohort 2. Dose and dosing frequency for Cohort 4 to be determined based on emerging data from Cohort 3.

Interventions

Oral CAB

CAB administered once orally on study Day 1 to the Stage 1: Single Oral Dose CAB (Cohort 1) and multiple times to the Stage 1: Multiple Oral Dose CAB (Cohort 2) group. Dose and dosing frequency for Cohort 2 to be determined based on emerging data from Cohort 1.

Intervention Type: DRUG

IM CAB LA

CAB LA administered once intramuscularly on study Day 1 to the Stage 2: Single IM Dose CAB LA (Cohort 3) group and multiple times to the Stage 2: Multiple IM Dose CAB LA (Cohort 4) group, into the in the anterolateral thigh muscle of participants. Dose for Cohort 3 to be determined based on emerging data from Cohort 2. Dose and dosing frequency for Cohort 4 to be determined based on emerging data from Cohort 3.

Intervention Type: DRUG

Other Intervention Names

Cabotegravir; Cabotegravir long-acting

Eligibility Criteria

Inclusion Criteria

• At least 37 weeks gestation at delivery.
• <=10 days of life.
• Birth weight at least 2 kg.
• At Entry, neonate has initiated standard of care Antiretroviral drug (ARV) prophylaxis.
• At Entry, neonate is generally healthy as determined by the site Investigator based on review of all available medical history information and physical examination findings.
• Mother is on a Dolutegravir (DTG) based regimen for a minimum of 4 weeks prior to delivery, regardless of maternal viral load.
• Mother is currently breastfeeding or plans to breastfeed infant.
• Mother is of legal age or circumstance to provide independent informed consent and is willing and able to provide documented informed consent for her and her infant's participation in this study.
• Mother has confirmed HIV-1 infection based on positive test results from 2 samples collected from 2 separate blood samples. Test results may be obtained from medical records or from testing performed during the study Screening period.

Exclusion Criteria

Medical conditions

• Severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by examining clinician.
• Known maternal-fetal blood group incompatibility which can result in hemolytic disease of the newborn.
• Known family history of G6PD deficiency.
• Prior/Concomitant therapy
• Mother who has previously received, is receiving, or will be receiving CAB post-partum.
• Neonate or breastfeeding mother is receiving any disallowed medication.
• Prior/Concurrent clinical study participation
• Neonate has exposure to other investigational drugs that might interfere with study intervention metabolism.
• Diagnostic assessments
• Mother has known Integrase strand transfer inhibitor (InSTI) resistance.
• At Entry, neonate with a confirmed, documented positive HIV Nucleic acid amplification test (NAAT) test result.
• At Screening, neonate has any of the following laboratory test results:

• Alanine transaminase or Aspartate aminotransferase of more than 2.5 x Upper limit of normal (ULN).
• Total bilirubin in range for phototherapy at Entry.
• Hemoglobin <13.0 g/dL.
• Decreased white blood cells Grade 3 or above.
• Platelets <50 000 cells/mm3
• Creatinine value more than 1.3 the ULN for postnatal age as defined in Division of AIDS (DAIDS)
• Albumin Grade 3 or higher.
• Direct bilirubin Grade 3 and above.
• Any other Grade ≥3 event on DAIDS toxicity table
• Mother or neonate has a condition that, in the site Investigator or designee's opinion, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
• At screening, QT interval corrected using Fridericia's formula >450 msec.

• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ViiV Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

US GSK Clinical Trials Call Center

Role: CONTACT

GSKClinicalSupportHD@gsk.com

877-379-3718

EU GSK Clinical Trials Call Center

Role: CONTACT

GSKClinicalSupportHD@gsk.com

+44 (0) 20 89904466

Other Identifiers

223560

Identifier Type: -

Identifier Source: org_study_id